Compliance with confidence

Welcome to Brandwood CKC, a trusted regulatory partner to the biomedical industries for more than 20 years. Our team's deep expertise, international network and proven strategic approach can help you successfully navigate the pathways to global market access.

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Events & Webinars

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23 March

Asia Pacific Device Summit

The Nixon Library Yorba Linda, California
30 November

Virtual Engineering Week Conference

Virtual. US - PST
11 January

BIO Partnering at JPM

Virtual. 11-15 January 2021.
8 December

FREE Webinar: Intellectual Property in China

Online. AEDT
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Biomedical Industry Updates

Biomedical news, views, insights and case studies from across the globe.

Pile of Documents

DOC’s will need to be submitted for new Class I IVD ARTG registrations

By Luis Jimenez | 26 November 2020
Similarly, to TGA’s recent notification on 1 October 2020, the TGA has issued a notice of upcoming changes for Class IVD registrations via an email...
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Formulated ingredients and premixes: Keeping the IP of a PI

By Nicole Tan | 24 November 2020
Formulated ingredients or premixes are commonly used in many medicinal products – such as inks, coatings and colourants, fragrances and flavours, dosage form bases, and...
Electronic Medical Record

TGA guidance for SaMD Regulatory “Carve Out”

By Homi Dalal | 19 November 2020
Following a public consultation on the Regulation of software, including Software as a Medical Device (SaMD) in early 2019, the TGA introduced several regulatory changes,...
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Video Gallery

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Our top 10 FAQs answered for 2020

Hitting the Accelerator! TGA’s Approaches to Speeding Up Medicine Approvals

Medical Device Regulations Under COVID – What You Need To Know

Blood, Sweat and Tears: An Update to In Vitro Diagnostics Regulatory Requirements Worldwide

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